Cochlear Americas Warehouse (manufacturer, Centennial, CO): 1 new FDA device listing, incl. active implantable bone conduction hearing system
Cochlear Americas Warehouse (Centennial, Colorado): 1 new FDA device listing, incl. active implantable bone conduction hearing system. Its amount of 1 is above the median of 1 (50th percentile). Dated 115 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 32 related CO DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Cochlear Americas Warehouse |
| Owner / operator | Cochlear Americas |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198 |
| Location | Centennial, CO, US |
| New listings | 1 |
| Devices | Active Implantable Bone Conduction Hearing System |
| Product codes | PFO |
| Device classes | Class II |
| Medical specialties | Ear, Nose, Throat |
| Brand names | Cochlear Osia Fitting Software 3; Cochlear Osia 3 Charger; Osia Smart App; Cochlear Osia 3 Aqua+; Cochlear Osia System; Cochlear Osia 3(I) Sound Processor; Cochlear Osia 3 Sound Processor |
| First new listing | 2026-07-13 |
| Latest new listing | 2026-07-13 |
| FDA registration number | 3014579188 |
| Registration expires | 2027-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (33 CO records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-07-13
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CO first): Simple Style Inc (specification developer, Brighton, CO) · Paragon 28 (manufacturer, Englewood, CO) · Terumo BCT STERILIZATION SERVICES, Inc. (contract sterilizer · Altivera Medical, Inc. (repackager or relabeler, Englewood, · Covidien (specification developer, Lafayette, CO) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Cochlear Americas Warehouse and 33 Colorado peers
- Colorado DeviceEstablishmentPulse records like this one: 33
- Cochlear Americas Warehouse's amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Colorado peer: $6,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Cochlear Americas Warehouse in Centennial, Colorado?
Cochlear Americas Warehouse (Centennial, CO), a manufacturer, added 1 FDA device listing on 2026-07-13.
How does Cochlear Americas Warehouse compare to other Colorado DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 115 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Cochlear Americas Warehouse vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Cochlear Americas Warehouse | Centennial, CO | 1 | 50th | 2026-07-13 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
| INNO Holdings Inc. | Millcreek, UT | 3 | 77th | 2026-10-05 |
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.